FDARecalled Aug 13, 2025 · #D-0552-2025
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals...
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit Classification: Class II Distribution: U.S Nationwide
Product details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Model numbers
- 230836C
- UPCs
- —